Quality & Regulatory Senior Executive

Company Overview

OPH Health Pte. Ltd. is a growinghealthcare technology company focused on medical systems, automation anddigital healthcare solutions across Southeast Asia.

As we continue to expand our business in Singapore and regional markets such as Indonesia and Malaysia, we are looking for a hands-on Quality & Regulatory Executive / Assistant Manager tosupport quality system implementation, regulatory coordination, supplierquality and customer quality matters.

This role is suitable for someone who isdetail-oriented, practical, willing to learn, and comfortable working in a leanand growing company environment.

Job Summary

The successful candidate will support andcoordinate quality and regulatory activities to ensure reliable productdeployment and compliant regional expansion.

The role will cover quality documentation,compliance follow-up, regulatory documentation, supplier quality coordination,customer quality issue tracking, and support for applications or maintenance ofrelevant licences, certifications and qualifications.

As OPH Health is a lean and growing team,the candidate should be hands-on and willing to personally handledocumentation, follow-ups and coordination work.

Key Responsibilities

·        Support the setup andmaintenance of quality and regulatory processes for healthcare products,medical systems and related solutions.

·        Prepare and maintain SOPs, workinstructions, forms, records, quality documents and document control processes.

·        Assist with audit preparation,corrective and preventive actions, non-conformance tracking, risk assessmentand compliance follow-up.

·        Support regulatorydocumentation and product registration activities for Singapore and regionalmarkets, especially Southeast Asia.

·        Coordinate with suppliers,manufacturers, consultants and internal teams to gather required regulatory andquality documents.

·        Track product registrations,licences, certifications, renewals, submission timelines and follow-up actions.

·        Support supplier documentationreview, supplier quality follow-up, customer complaint tracking and fieldquality issue closure.

·        Prepare quality and compliancedocuments for product delivery, installation, commissioning, customer support,audits, partner onboarding and tender submissions.

·        Support the application,renewal and maintenance of relevant company, product or operationalqualifications, licences and certifications.

·        Work closely with managementand internal teams to ensure quality and regulatory matters are followedthrough properly.

Requirements

·        Diploma or Degree in BiomedicalEngineering, Life Sciences, Pharmacy, Regulatory Affairs, Quality Management,Engineering or a related discipline.

·        Minimum 2-5 years of relevantexperience in quality assurance, regulatory, healthcare products, medicaldevices, pharmaceutical, life sciences, manufacturing or related industries.

·        Experience in qualitydocumentation, document control, audits, corrective and preventive actions,non-conformance handling or compliance follow-up will be an advantage.

·        Exposure to ISO 13485, ISO9001, GDP, GDPMDS, GMP or similar quality frameworks will be an advantage.

·        Exposure to HSA registration,medical device registration, product registration or regulatory documentationwill be an advantage.

·        Familiarity with SoutheastAsian regulatory requirements, especially Indonesia and Malaysia, will be anadded advantage but is not mandatory.

·        Strong attention to detail,documentation discipline and follow-through.

·        Able to work independently andmanage follow-up actions responsibly.

·        Comfortable working in a lean,fast-paced and evolving company environment.

·        Practical, hands-on and willingto handle documentation and coordination directly.

·        Good communication andcoordination skills with internal teams, suppliers, consultants and externalstakeholders.

·        Able to communicate effectivelyin English. Mandarin communication ability will be an advantage forcoordination with Mandarin-speaking internal technical and supplier teams.

Preferred Attributes

·        Hands-on and willing to learn.

·        Organised, careful anddetail-oriented.

·        Able to follow through on tasksfrom start to closure.

·        Comfortable working in a smallteam with changing priorities.

·        Proactive in identifying gaps,pending items and required follow-ups.

·        Practical and able to balancecompliance requirements with business needs.

·        Interested in healthcaretechnology, medical systems and regional business expansion.

Why Join Us

·        Opportunity to join a growinghealthcare technology company expanding across Southeast Asia.

·        Exposure to quality,regulatory, supplier and customer quality functions.

·        Opportunity to work closelywith management and cross-border teams.

·        Suitable for someone who wantsto grow into a broader quality and regulatory role.

·        Hands-on role with learningopportunities in healthcare products, medical systems and regional marketexpansion.